1. The Field of the Invention
The present invention relates to kits and methods for treating disordered tissue and/or prodromal stage tissue caused by a virus, such as herpes virus, that combine systemic and topical treatments.
2. The Relevant Technology
Tissue disorders caused by viruses, particularly those which impact epithelial tissue, include Herpes simplex virus types I and II, herpes zoster, varicella-zoster, cytomegalovirus, and HHV-8, which causes Kaposi's Sarcoma, and Ramsay Hunt syndrome. Such viruses can cause painful, disfiguring and/or highly infectious disordered tissues (e.g., blisters or lesions), which are physically and psychologically debilitating. Disordered tissues caused by viruses are often difficult to treat and the resulting damage can last a lifetime.
Herpes simplex virus types I and II and herpes varicella-zoster, commonly referred to as “herpes virus” or “herpes,” are infectious diseases which have reached crisis proportions nationally with estimated numbers of infected people at 70%-80% of U.S. population as reported by the American Social Health Association (ASHA) and growing annually by 500,000 people or more.
Herpes can enter the human body through minuscule breaks in the epidermal tissue, orally, through the eye, or body fluid, usually by contact with an infected host, and is marked by eruption of one or more vesicles, usually in groups, following an incubation period of approximately four to ten days. Typically the course of the infectious outbreak initiates with the prodromal stage, in which prodromal stage tissue can be associated with paresthesia (or abnormal tingling or pricking sensation), advancing to vesicular eruption, followed by ulceration, coalescing, resolution, and latency period. The outbreak can last for several weeks and, on average, lasts two to three weeks. In some immune compromised individuals, outbreaks can last for months. The lesions caused by varicella-zoster (shingles) can last 21 days or longer. The vesicles can appear anywhere on epithelial tissues including the skin or mucosa, typically appearing on the lips as cold sores, glands, oral mucosa, conjunctiva and cornea, genitalia, anal mucosa and perianal tissue.
Herpes symptoms include: paresthesia, inguinal swelling, pain, fever, malaise, headaches, muscle aches, and swollen glands. Some individuals with oral herpes, which impacts the trigeminal nerve, have excruciating facial pain, difficulty swallowing, eating and facial swelling. Individuals with the herpes that impacts the sacral nerve have severe upper leg pain, swelling, and great difficulty walking.
Herpes is recurring, residing in the nerve ganglia, followed by recurrences due to some, not fully understood, stimulus mechanism. Recurrent herpetic infections can be precipitated by almost anything, including overexposure to sunlight, nutritional deficiencies, stress, menstruation, immunosuppression, certain foods, drugs, febrile illness, suppression of the immune system, and the like.
Herpes infections pose serious health threats, often causing blindness, increased cancer risk of the cervix, aseptic meningitis and encephalitis, neonatal deaths, viremia, the spread of the human immunodeficiency virus (HIV), and the like. The devastating effects of herpes diseases go well beyond the medical scope of human suffering. Herpes can be responsible for serious psychological and emotional distress as well as substantial economic loss. Other viral diseases are transmitted in different manners and may have different symptoms but can be as painful emotionally and physically to a patient.
The most common FDA-approved therapeutic treatment of herpetic or other viral disorders is through systemic treatment, such as using nucleoside analogs or other drugs that inhibit or interrupt replication of the virus causing the tissue disorder. Systemic treatments can be taken orally or intravenously and can prevent or inhibit outbreaks. Systemic treatment generally inhibits or disrupts the reproductive cycle of the target virus. However, systemic treatment can take a significant amount of time to metabolize and convert into the active form. Once in active form, the systemic medication must be delivered throughout a patient's entire body to curtail virus replication. During the time required to deliver the medication to the patient's body, the patient can still experience outbreaks that cause significant discomfort while the patient waits for the medication to take effect. In addition, the stratum basal layer can prevent medication from passing through to the epidermis so that infected regions of the epidermis continue to experience the outbreak cycle. Hence, systemic treatments may be ineffective in treating an existing outbreak of skin lesions, including the pain and discomfort experienced by the patient. Furthermore, a person can re-infect themselves by touching an infected outbreak area (even while taking a systemic medication) and exposing another area of their body with the virus.
In contrast to systemic treatments, topical treatments are intended to reduce the pain and severity associated with disordered tissues caused by herpes or other viruses. They can be soothing as a salve over the tender surface of the disordered tissue. However, they rarely if ever provide actual therapeutic treatment of the underlying cause of the disorder, which is the system-wide existence of virus in the person's body.
In view of the widespread nature of herpes and other viral caused disordered tissues, coupled with the general ineffectiveness of existing treatments, there exists an ongoing need to develop effective treatments that can shorten, reduce or eliminate outbreaks of disordered tissues.